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HHS/FDA RIN: 0910-AF77 Publication ID: Spring 2008 
Title: Natural Rubber-Containing Medical Device; User Labeling(Completion of a Section 610 Review) 
Abstract: FDA has under taken a review of 21 CFR part 801 under section 610 of the Regulatory Flexibility Act. The purpose of the review was to determine whether the regulations in part 801 should be continued without change, or whether they should be amended or rescinded, consistent with the stated objectives of applicable statutes, to minimize any significant economic impact on a substantial number of small entities. FDA has solicited comments on the following (1) The continued need for the regulation in part 801; (2) the nature of complaints or comments received concerning the regulation in part 801; (3) the complexity of the regulation in part 801; (4) the extent to which the regulation in part 801 overlap, duplicates, or conflict with other Federal, State, or governmental rules: and (5) the degree to which technology, economic conditions, or other factors have changed in the area affected by the regulation in part 801. The section 610 review has been carried out along with a regulation review under section 5 of Executive Order 12866, which calls for agencies to periodically review existing regulations to determine whether any should be modified or eliminated so as to make the agency's regulatory program more effective in achieving its goals, less burdensome, or in greater alignment with the President's priorities and the principles set forth in the Executive Order. The agency did not receive any comments during the review process of part 801 under section 610 review. FDA's review of this regulation concluded that it should be continued without change. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Completed Actions 
Major: No  Unfunded Mandates: No 
RFA Section 610 Review: Completion of a Section 610 Review 
CFR Citation: 21 CFR 801.437 
Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 357; 21 USC 360i; 21 USC 360j; 21 USC 371; 21 USC 374 
Legal Deadline:
Action Source Description Date
Other  Statutory  Planned section 610 review  09/30/2007 
Action Date FR Cite
Final Action  09/30/1997  62 FR 51021 
Begin Review of Current Regulation  01/02/2007   
End Review of Current Regulation  12/28/2007   
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: Yes 
Agency Contact:
Nancy Pirt
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health, WO 66, Room 4438, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:301 796-6248
Fax:301 847-8145

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